Brief Summary
Given the likelihood of COVID-19 remaining an endemic disease among high-risk populations, establishing effective mitigation interventions will be critical to stemming community transmission. Criminal justice-involved individuals are extremely important to reducing community-based SARS-CoV-2 transmission due to their increased risk of contracting SARS-CoV-2 while incarcerated and their likelihood of living in congregate settings after incarceration. The investigators will evaluate an onsite Point-of-Care SARS-CoV-2 testing and education strategy in a corrections-focused community-based organization and its impact on improving testing uptake, mitigation behaviors(e.g. mask wearing, hand hygiene, social distancing, vaccine uptake when available), and cost-effectiveness.
Brief Title
Leveraging CHWs to Improve COVID-19 Testing and Mitigation Among CJIs Accessing a Corrections-focused CBO
Detailed Description
The United States(U.S.) has experienced higher mortality than any other nation due to COVID-19 with nearly 13.5 million cases and over 268,103 deaths. Due to the limited ability to socially distance, poor ventilation, and limited hygiene supplies, U.S. prisons and jails have observed explosive transmission of SARS-CoV-2 accounting for the 10 largest U.S. outbreaks. Because 95% of criminal justice-involved individuals reenter societyCOVID-19 transmission extends beyond those who are currently incarcerated. As justice-involved individuals reenter the community, they face high rates of homelessness, and many others live in other congregate settings such as converted hotels and halfway houses. The increased risk of SARS-CoV-2 while incarcerated coupled with the likelihood of living in congregate settings after incarceration, create conditions ripe for rapid COVID-19 transmission that will be critical to address in order to gain control of COVID-19 in the U.S. The goal of this study is to test the impact and cost-effectiveness of an intervention to mitigate SARS-CoV-2 transmission among justice-involved individuals recently released from incarceration. The investigators will conduct a randomized trial to compare the effectiveness of an onsite Point-of-Care SARS-CoV-2 testing and education intervention with community health workers (CHWs) as a central component compared to the standard of care at a community-based organization (CBO) that provides services to justice-involved individuals in New York City. The investigators will measure costs of testing, education, and navigation, and explore the cost-effectiveness of the onsite Point-of-Care intervention compared to the standard of care. The specific aims are to:1) Test the effectiveness of an onsite PoC SARS-CoV-2 intervention in a corrections-focused CBO; 2) Model the cost-effectiveness of an onsite PoC SARS-CoV-2 intervention among CJIs compared to SoC. Because testing, education, and navigation will be provided by CHWs in a culturally-sensitive environment and test results will be received in minutes (rather than days), the investigators hypothesize that O-PoC will be associated with improved testing uptake and receipt of test results, mitigation behaviors (mask wearing, hand hygiene, social distancing), and those who attend more O-PoC sessions will have better adherence to mitigation behaviors.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Covid19
Eligibility Criteria
Inclusion Criteria:
* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days
Exclusion Criteria:
* Inability to provide informed consent
* Inability to complete study visits over 12 months
* Does not plan to reside in the NYC area for the next year
* Terminal illness
* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days
Exclusion Criteria:
* Inability to provide informed consent
* Inability to complete study visits over 12 months
* Does not plan to reside in the NYC area for the next year
* Terminal illness
Inclusion Criteria
Inclusion Criteria:
* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days
* Fortune Society clients
* Greater than or equal to 18 years old
* Fluent in English or Spanish
* Resident of NYC
* Released from a jail or a prison system within 90 days
Gender
All
Gender Based
false
Keywords
COVID19
justice-involved individuals
Point-of-care testing
community based organization
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04878328
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12976
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Leveraging Community Health Workers to Improve COVID-19 Testing and Mitigation Among Criminal Justice-involved Individuals Accessing a Corrections-focused Community-based Organization
Primary Outcomes
Outcome Description
Testing uptake will be defined as the number and proportion of tests performed and will be determined using Program logs and healthcare record extraction. For all participants, the proportion of tests will be calculated from the total possible denominator of 5 tests (at times 0, 3, 6, 9, and 12 months). Receipt of test results will be defined as the number and proportion of test received and will be determined by self-report
Outcome Measure
Testing uptake
Outcome Time Frame
12 months
Secondary Ids
Secondary Id
5R01MD016744
Secondary Outcomes
Outcome Description
For mitigation measures, participants will be asked: Which of the following have you done in the last 14 days to keep yourself safe from coronavirus? Worn a mask or other face covering; Washed your hands with soap or used hand sanitizer; Avoided contact with people who could be high-risk; Avoided public spaces, gatherings, or crowds.For answers to which the answer is yes: The investigators will ask questions about mitigation measures on a sliding Likert scale regarding the last 14 days that will be programmed into Ethica software. Likert scales will include a legend with both numbers (1 day-14 days). The investigators will assign a score with higher adherence to mitigation measures as higher scores (from 1 to 14) and create a composite score averaging 2-week questionnaire conducted over the course of the 3 months following PoC intervention visits for each mitigation measure.
Outcome Time Frame
12 months
Outcome Measure
Mitigation measures
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthew Akiyama
Investigator Email
makiyama@montefiore.org